The following data is part of a premarket notification filed by Aziyo Biologics, Inc. with the FDA for Cangaroo Neuro Envelope (small) ; Cangaroo Neuro Envelope (medium) ; Cangaroo Neuro Envelope (large) ; Cangaroo Neuro Envelope (extra Large).
| Device ID | K182255 |
| 510k Number | K182255 |
| Device Name: | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra Large) |
| Classification | Mesh, Surgical |
| Applicant | Aziyo Biologics, Inc. 1100 Old Ellis Road, Suite 1200 Roswell, GA 30076 |
| Contact | Wendy Perreault |
| Correspondent | Wendy Perreault Aziyo Biologics, Inc. 1100 Old Ellis Road, Suite 1200 Roswell, GA 30076 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2018-11-15 |
| Summary: | summary |